Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as an Adjuvant Treatment in Endometrial Carcinoma

Endometrial Carcinoma Clinical Trial

Official title:

Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as an Adjuvant Treatment in Endometrial Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06102252
• Other study ID #: soh-Med-23-10-8MS
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: November 2025

Study information

• Verified date: October 2023
• Source: Sohag University
• Contact: ASMAA G GAMAL, assistant lecutrer
• Phone: 01003773633
• Email: asmaa.gamal[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endometrial cancer, the most common gynecologic cancer worldwide, is steadily increasing in developed countries.The early-stage forms of endometrial cancer are usually highly curable by surgical treatment alone, whereas advanced stages require adjuvant interdictions such as radiotherapy and chemotherapy. Platinum and anthracycline drugs have long been used as standard adjuvant chemotherapy drugs for advanced and recurrent endometrial carcinomas. In one study, the standard combination adjuvant treatment with AP was found to be more effective as an adjuvant therapy than whole abdominal irradiation

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:• Age group: Histologically diagnosed with primary endometrial carcinoma

• more than 20 years old.
• Any histological type of endometrial carcinoma
• Stage III, IV
• Stage one I or II with one or more of the following factors:

1. Histologic grade 3 endometroid carcinoma with myometrial invasion still within half of the myometrium

2. histological grade 1,2 endometroid carcinomas with invasion of over half of myometrium

3. cervical stromal invasion

4. vascular invasion; or

5. serous carcinoma, clear cell carcinoma, or undifferentiated carcinoma

• performance status 0-2
• adequate function of all major organs

Exclusion Criteria:

• • Pt has received prior radiation or chemotherapy.
• Pt with sarcomatous component
• Metastatic endometrial carcinoma
• Other malignancy
• Unfit patient for chemotherapy

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Carcinoma
• Endometrial Neoplasms

Intervention

Drug:
• Paclitaxel/epirubcin/carboplatin
adjuvant treatment in endometrial carcinoma
• Paclitaxel/carboplatin
Dose dense paclitaxel/carboplatin

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Bestvina CM, Fleming GF. Chemotherapy for Endometrial Cancer in Adjuvant and Advanced Disease Settings. Oncologist. 2016 Oct;21(10):1250-1259. doi: 10.1634/theoncologist.2016-0062. Epub 2016 Jul 13. — View Citation

Colombo N, Creutzberg C, Amant F, Bosse T, Gonzalez-Martin A, Ledermann J, Marth C, Nout R, Querleu D, Mirza MR, Sessa C; ESMO-ESGO-ESTRO Endometrial Consensus Conference Working Group. ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer: Diagnosis, Treatment and Follow-up. Int J Gynecol Cancer. 2016 Jan;26(1):2-30. doi: 10.1097/IGC.0000000000000609. — View Citation

Fujiwara K, Egawa-Takata T, Ueda Y, Kimura T, Yoshino K, Fujita M, Miyatake T, Ohta Y, Kamiura S, Enomoto T, Kimura T. Investigating the relative efficacies of combination chemotherapy of paclitaxel/carboplatin, with or without anthracycline, for endometrial carcinoma. Arch Gynecol Obstet. 2012 May;285(5):1447-53. doi: 10.1007/s00404-011-2154-9. Epub 2011 Nov 30. — View Citation

Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group Study. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Jan 1;24(1):36-44. doi: 10.1200/JCO.2004.00.7617. Epub 2005 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate of chemotherapy	6 cycles	6 months